Chronic Pain
Conditions
Keywords
buprenorphine
Brief summary
The COVID-19 pandemic is exacerbating the challenges faced by Veterans at risk of opioid overdose including Veterans prescribed moderate-to-high dose long-term opioid therapy (LTOT) whose usual treatment resources and coping strategies may be inaccessible. This project combines established VA care components to deploy and evaluate virtual models of care for Veterans on high-risk LTOT to meet the dual challenges of maintaining social distancing and delivery high quality care.
Interventions
OTHERVCPM
VCPM is a multi-component intervention consisting of already-established care processes and materials.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This single-arm feasibility study will be conducted in two VA sites.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible participants must currently receive LTOT for chronic pain at 50 mg morphine equivalent daily dose
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer | 30 days | Using shared decision-making with Veterans, we will based the measure on clinical reports of patient change in opioid regimen. This would be tapering (reducing opioid dose), discontinuation, or transfer to buprenorphine. Any reduction or change was considered positive for change, even if the patients returned to their initial dose. The number of patients who agree to change their opioid regimen provides a realistic indicator of overall feasibility/acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Retained in Care at End of Study | 60 days | Of participants who engaged in initial treatment the number who completed or were retained in care at the end of the study provides a outcome measure of engagement |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VCPN Single Arm for this single arm all participants receive VCPM | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | continued care with their physician | 20 |
| Overall Study | treatment needs outside scope of VCPM | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | VCPN Single Arm |
|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 44 |
| other Total, other adverse events | 2 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer
Using shared decision-making with Veterans, we will based the measure on clinical reports of patient change in opioid regimen. This would be tapering (reducing opioid dose), discontinuation, or transfer to buprenorphine. Any reduction or change was considered positive for change, even if the patients returned to their initial dose. The number of patients who agree to change their opioid regimen provides a realistic indicator of overall feasibility/acceptability.
Time frame: 30 days
Population: All participants who completed the initial CPS visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VCPM | The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer | 19 Participants |
Secondary
Number of Participants Retained in Care at End of Study
Of participants who engaged in initial treatment the number who completed or were retained in care at the end of the study provides a outcome measure of engagement
Time frame: 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VCPM | Number of Participants Retained in Care at End of Study | 17 participants |